Method and device for forming pre-made pouches

ABSTRACT

An apparatus and method for forming cavities in pouches. The packages are used for packaging sterile medical products. The apparatus has a frame and a tongue plate member. A pouch is placed onto the tongue plate member to form a cavity into at least one side of the pouch.

FIELD OF THE INVENTION

The field to which this invention relates is packaging machinery andprocesses, in particular, packaging and machinery for forming medicaldevice packages.

BACKGROUND OF THE INVENTION

Pouch-type packaging is very flexible and adaptable to a variety ofmedical products, including medical devices. An example of a pouch-typepackage without formed cavities is two flat similarly sized rectangularsheets of material aligned and placed directly over one another andsealed together along three of their four edges. The fourth edge is leftopen to form the pouch and provide an entrance opening into the interiorof the pouch. The fourth side may be sealed after a product such as amedical device is placed inside the pouch (often referred to the fillingprocess). This operation is not typically conducted in a sterileenvironment, although it may be. Therefore, it is then desirable tosterilize the product that is now contained within the pouch, along withthe interior of the pouch, in order to provide a sterile product.Various types of sterilization processes are known in the art tosterilize medical products, including gas sterilization, autoclaving,gas plasma sterilization, radiation and other conventional processes.When utilizing a gas sterilant process such as ethylene oxide, one ofthe flat rectangular sheets may include a gas permeable barrier such asa TYVEK® sheet. Sterilization gases can penetrate the gas permeablebarrier to sterilize the product inside the sealed pouch. Once thesterilization process is completed, a fifth seal may be made to isolatethe product from the gas permeable section of the sealed pouch.Following this operation, the portion of the pouch that contains the gaspermeable barrier is removed. When using two sheets which are not gaspermeable, the package is sealed along the fourth edge after ethyleneoxide sterilization in a clean room.

Forming is defined as the process of creating a cavity in one or bothsheets of material used to form the pouch to accommodate a product to bepackaged. Formed cavities are especially useful in pouch-type packagesbecause they allow larger products to be housed or filled within a givensize pouch without the formation of wrinkles. Wrinkle formation in oneor both sheets is typical of a non-formed pouch package. These wrinklescan be eliminated if one or both sheets have pockets formed in them toaccommodate the intended product. There may be disadvantages associatedwith such wrinkles, including channels and unsealed sections or areaswhich result is a loss of sterility and barrier to moisture and oxygen.

Flat pouches are typically made form roll stock on seal and cutequipment. Pouches may be formed from two rolls of laminate foilmaterial such rolls of heat sealable packaging materials. Thesematerials can be foil laminates, films, heat sealable papers or spunbonded plastics. Thermo forming is performed on films while coldpressure forming is typical for foil laminates Forming process typicallyare performed on conventional form/fill/seal equipment. These types ofsystems can easily fabricate numerous flat pouches or envelopes that maybe later transported to subsequent operations for filling and finalsealing as described above. As previously mentioned, it is oftendesirable to have a formed cavity in one or both sides of the pouch.This is accomplished by forming a cavity in one (or both) sheet(s),placing the product into a cavity, and then placing and sealing the twosheets together. Where cavities are formed in both sheets, care must betaken to assure accurate registration and alignment of the sheets beforethey are sealed. This type of process may be automated as a continuousprocess wherein package formation, filling with product, and sealing areall conducted in a continuous manner. This type of system works well formost products that are not sterile, however, it does not work well forsterile product that needs to be aseptically filled and sealed into thepouch.

Aseptic packaging processes and equipment are known in the art.Aseptically filling and sealing a product into a package is typicallyconducted in an aseptic environment. Such environments are difficult andcostly to fabricate on a scale large enough to accommodate form, fill,and seal systems as described above. One approach used for asepticpackaging is to manufacture pouches in a non-sterile environment, stackthem, sterilize them, and then transfer them into an aseptic environmentfor the filling and sealing operation. This process works well withpouches that are not formed. However, formed pouches present someadditional challenges. Formed pouches, when stacked take up much morespace and therefore fewer pouches can be accommodated in each stack.Even if gently stacked, the pouches are typically easily damaged duringthe sterilization process and subsequent transport into an asepticenvironment. Damage may include wrinkle formation and hole formation.Wrinkled or unsupported surfaces present yet additional challenges whenthe application of labels on the outer package surface is desired.

Therefore, there is a need for novel packaging processes and machinesfor making pouches having formed cavities adapted for use in an asepticenvironment.

SUMMARY OF THE INVENTION

Accordingly, a novel apparatus for manufacturing pouches having cavitiesis disclosed. The apparatus has a frame. A bottom or lower clamp platemember is slidably mounted to the frame. The bottom plate member has atop side and a bottom side. A top die plate member is slidably mountedto the frame. The top plate member has a top side and a bottom side.First and second actuators are mounted to the frame for moving thebottom plate member and the top plate member toward each other. There isa die member extending from the bottom of the top plate member.Optionally, a die member extends from the top side of the bottom platemember. The die member has a cavity. The apparatus also has a tongueplate member plate having a first end and a second end. The second endof the tongue member is fixedly mounted to the frame between the topplate member and the bottom plate member such that the tongue memberextends between the top plate and the bottom plate. The tongue memberhas a fluid passage having a first opening, and a second opening throughthe top side. The first and second openings are in communication withthe fluid passage. Optionally, the tongue member has an opening on thebottom side.

Another aspect of the present invention is a method of manufacturing apouch having a cavity using the above described apparatus. In thismethod, a pouch is provided. The pouch has two sheets aligned and sealedalong three sides such that the pouch has an unsealed side and anopening into an interior. An apparatus of the present invention isprovided. The apparatus has a frame. A bottom or clamp plate member isslidably mounted to the frame. The bottom plate member has a top sideand a bottom side. A top die plate member is slidably mounted to theframe. The top plate member has a top side and a bottom side. First andsecond actuators are mounted to the frame for moving the bottom platemember and the top plate member toward each other. There is a die memberextending from the bottom of the top plate member. The die member has acavity. The apparatus also has a tongue plate member having a first endand a second end. The second end of the tongue member is fixedly mountedto the frame between the top plate and the bottom plate such that thetongue member extends between the top plate member and the bottom platemember. The tongue member has a fluid passage having a first opening,and a second opening through the top side. The first and second openingsare in communication with the fluid passage. The pouch is placed overthe tongue member, such that a section of the tongue member is containedwithin the interior of the pouch. The top and bottom plate members aremoved toward each other such that the die contacts the top of the pouchand the bottom plate member contacts the bottom of the pouch against thebottom and top surfaces of the tongue member, respectively. Apressurized fluid is caused to move into the fluid passage of the tongueand out through the second opening, thereby causing a section of the topsheet of the pouch to be forced into the cavity of the die, and therebyforming a cavity in the top sheet. The top and bottom plate members areaway from the tongue member, and, the pouch having a formed cavity isremoved from the tongue member.

These and other aspects and advantages of the present invention willbecome more apparent from the following description and accompanyingdrawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a pouch of the present invention priorto processing to form a cavity.

FIG. 2 a is a perspective view of a machine of the present inventionuseful to manufacture pre-formed pouches illustrating the front of themachine.

FIG. 2 b is a perspective view of a machine of FIG. 2 a illustrating theback of the machine.

FIGS. 3 a and 3 b are perspective views of the machine of FIG. 1illustrating an unformed pouch being inserted over the tongue memberprior to forming a cavity in the pouch

FIGS. 4 a and 4 b are perspective views of the machine of FIG. 1illustrating the plate members closed about the tongue member and pouchfor the cavity forming step.

FIGS. 5 a and 5 b are perspective views of the machine of FIG. 1illustrating the plate members opened after the cavity forming step andillustrating a cavity formed in the pouch prior to removal from thetongue member and the machine.

FIG. 6 is a perspective view of a tongue member used in the machine andprocess of the present invention

FIG. 7 is a perspective view of a lower clamp plate member of themachine of the present invention.

FIG. 8 is a perspective view of a cavity plate member of the machine ofthe present invention.

FIG. 9 is a perspective view of the pouch of FIG. 1 after it has beenprocessed using the machine and process of the present invention to forma cavity therein.

FIG. 10 is a perspective view of the pouch of FIG. 9 after it has beenfilled with a medical device and sterilized.

DETAILED DESCRIPTION OF THE INVENTION

The pouches useful in the practice of the present invention are madefrom sheets of flat materials know in this art useful for forming pouchpackages for sterile medical products, particularly medical devices.Typically, each sheet is made from a conventional foil or a foillaminate made from materials such as aluminum foil, polymer sheets,coatings and the like, e.g., polyester/foil/polyethylene heat sealcoating. Optionally, a first sheet is made from the previously describedfoil laminate, and the second sheet is made from a conventionalgas-permeable polymeric material such as TYVEK spunpolytetraflouroethane, heat seal coated medical grade paper, and thelike. Optionally the second sheet can be made from a metal foil laminateand can have a vent opening with a section of a gas permeable polymericsheet affixed over the vent opening. In addition, the second sheet isoptionally a conventional polymeric gas impermeable sheet such aspolethylene, polyester, halogenated films such as Aclar and PVC, and thelike. The sheets of materials are bonded together via a peripheral sealin a conventional manners including heat sealing, ultrasonic welding,radiofrequency, microwave, gluing and the like. Packages using pouchesand methods of packaging sterile medical devices are disclosed in thefollowing U.S. Patents, which are incorporated by reference: U.S. Pat.No. 5,868,244; U.S. Pat. No. 5,732,529; U.S. Pat. No. 5,623,810; and,U.S. Pat. No. 4,482,053.

A flat pouch 10 useful in the practice of the process of presentinvention is illustrated in FIG. 1. The pouch 10 is seen to have topfoil sheet 30 and bottom foil sheet 40. The pouch 10 is seen to besealed about the periphery of three sides using a conventional sealingprocess such as heat sealing or equivalent processes to form seal 50.The seal 50 has lateral sides 52 and bottom side 54. The pouch 10 hasopen top side 15 with entrance opening 20 to interior cavity 22. Thepouch 10 is seen to have optional gas vent 12. Referring to FIG. 9, thepouch 10 is seen after processing using the equipment and process of thepresent invention to have a cavity 60 formed into bottom sheet 30. Asterile package 10 of the present invention after filling with a medicaldevice 70 and subsequent sealing (and conventional gas sterilization) isseen in FIG. 10. The package 10 is seen to have top side 15 sealed bytop seal 56, with the section of the package containing optional vent 12removed in a conventional manner such as by cutting. If the pouch 10does not have a gas vent, it may be filled with a medical device,sterilized with a conventional gas process, and then aseptically sealed.Optionally, other types of sterilization processes may be used includingconventional plasma, radiation and autoclaving sterilization processes,and in the case of radiation and autoclaving, the pouch of the presentinvention having a cavity may be hermetically sealed prior to thesterilization process.

A novel package forming machine 100 of the present invention isillustrated in FIGS. 2-8. Machine 100 is seen to have bottom base member1 10. Extending upwardly from the top 112 of the base member 100 are theguideposts 120, having bottoms 122 and tops 124. Mounted to the tops 124of the posts 120 is the top plate member 140. The plate members 110 and140 may be mounted to the bottoms 122 and 124 of posts 120 in aconventional manner such as screw head cap screws, nuts, welding,fittings, and the like. The lower cylinder actuator 160 is seen to bemounted to the top 112 of base member 110. Cylinder actuator 160 is seento have cylinder 162 and actuator rod 164 having end 166. The lowerclamp plate or bottom plate member 170 is slidably mounted to theguideposts 120 through guidepost openings 175. Plate member 170 hasbottom 177 and top 178. Extending from one side of the plate member 170is the extension member 180. The end 164 of actuator rod 164 isconnected to the bottom side 177 of plate member 170. Upper cavity platemember 190 is seen to be slidably mounted to the guideposts 120 throughthe guidepost openings 195. Plate member 190 has top side 198 and bottomside 197. Mounted to the bottom 144 of top plate member 140 is theactuator cylinder 220. Actuator cylinder 220 has cylinder 222 andactuator rod 224 having end 226. End 226 of actuator cylinder 220 ismounted to the top 198 of cavity plate member 190. Extending downwardlyfrom the bottom side 197 of cavity plate member 190 is the die member200. Die member 200 is seen to have raised opposed sides 202 and 204.The sides 202 and 204 extend above bottom 205 and surround cavity 207formed by the sides 202 and 204 and the bottom 205. Extending up fromthe top 112 of bottom plate 110 is the mounting tower 230. Tower 230 hastop 232 and bottom 234. The forming tongue member 240 is seen to havetop 242 and bottom 244, and ends 246 and 248. Extending from end 246 offorming tongue member 240 is the gas manifold member 249. The manifoldmember 249 has connection 250 in communication with gas passage 252contained in member 240. Discharge opening 255 extends through the top242 and is in fluid communication with passage 252. Discharge opening242 is in alignment with cavity 207 of die member 200. The end 246 oftongue member 240 is fixedly mounted to the top 232 of tower member 230such that the member 240 extends in a cantilevered fashion between thetop 178 of plate member 170 and the bottom 197 of top plate member 190,and over extension member 180.

The machine 100 of the present invention operates in the followingmanner to form cavities in pouches utilizing the process of the presentinvention. As seen in the FIGS. 2-8, an operator faces the side of themachine 100 opposite the side where the mounting tower 230 is located,and facing free end 248 of forming tongue member 240. In the startingposition, the actuating cylinders 160 and 220 move the plates 170 and190 downwardly and upwardly, respectively, to form an opening about theforming tongue member 240. The operator then takes a pouch 10 and movesthe top side 15 and entrance opening 20 over the free standing end 248of the tongue member 240 and slides the pouch 10 onto section 242 untilthe end 15 of the pouch 10 engages or is proximal to the free end 248 oftongue member 240, and tongue member 240 is contained in part ininterior cavity 22 of pouch 10. The operator then actuates the cylinders160 and 220 to move the plates 170 and 190 upwardly and downwardly,respectively, so that the top side 178 of plate 170 is in contact withthe bottom sheet 40 of pouch 10 pressing it against the bottom of tonguemember 240 and die member 200 is in contact with a section of the topsheet 30 of pouch 10 pressing it against the top of and tongue member240. The operator then actuates a pressurized fluid supply such as airconnected to manifold 248 causing the air to flow through the passage252 in member 248 and exit through second opening 255 thereby pushingand forming the section of the top sheet 30 engaged between the sidewalls 202 and 204 of die member 200 into the cavity 207 of die member200 thereby forming cavity 60 in sheet 30 of pouch 10, havingsubstantially the shape of cavity 207. The operator then actuates thecylinders 160 and 220 to reverse their movement to pull plates 170 and190 away from each other such that there is an opening about the tonguemember 240. The operator then removes the pouch 10 having cavity 60 fromtongue member 240, and proceeds to repeat the operation to form cavitiesin unformed pouches 10.

Although this invention has been shown and described with respect todetailed embodiments thereof, it will be understood by those skilled inthe art that various changes in form and detail may be made withoutdeparting from the spirit and scope of the claimed invention.

What is claimed is:
 1. An apparatus for forming a cavity in a pouch thatis sealed on three sides, comprising: a frame; a bottom clamp platemember slidably mounted to the frame, said bottom plate having a topside and a bottom side, the bottom clamp plate member moveable between afirst position and a second position; a top die plate member slidablymounted to the frame, said top plate having a top side and a bottomside, the top die plate member moveable between a first position and asecond position; first and second actuators for moving the bottom plateand the top die plate toward each other; a die extending from the bottomof the top die plate member, said die having a cavity; a mounting towermember having a top and a bottom, the bottom of the tower member mountedto the frame; a tongue plate member [e] having a first free end and asecond end, the plate member having a substantially flat planar top anda substantially flat planar bottom, the second end fixedly mounted tothe top of the tower member and the tongue member extending between thetop die plate member and the bottom clamp plate member, the tonguemember having a fluid passage having a first opening and second openingthrough the top side, wherein the second opening is in substantialalignment with the cavity of the die, said first and second openings incommunication with the fluid passage.
 2. The apparatus of claim 1,wherein the frame comprises a base plate, at least two support membersextending up from the base plate, and a top plate mounted to the supportmembers, wherein the bottom plate member and the top die plate memberare slidably mounted to the support members.
 3. The apparatus of claim1, wherein the first opening is adapted to be connected to a source ofpressurized fluid.
 4. The apparatus of claim 1, wherein the actuatorscomprise gas cylinders.
 5. The apparatus of claim 1, wherein theactuators comprise hydraulic cylinders.
 6. The apparatus of claim 1,wherein the actuators comprise power screws driven by electric motors.7. The apparatus of claim 1 wherein the top die plate member and thebottom clamp plate member have openings therein to slidably receive thesupport members.
 8. The apparatus of claim 1, wherein the bottom clampplate member additionally comprises a die member having a cavityextending from the top of the bottom clamp plate member, and the tonguemember comprises an additional third opening extending through thebottom of the tongue member in communication with the fluid passage.